Mylan Clears the Way to Potential Trastuzumab Biosimilar Launch

A settlement reached with Genentech and F. Hoffmann-La Roche Ltd. should allow Mylan to launch its biosimilar version of Herceptin® soon after the completion of its Food and Drug Administration (FDA) review in September. Mylan, which holds a partnership agreement with Biocon, will market the new trastuzumab biosimilar once approved.

Under the agreement, Mylan will have a global license to commercialize the agent (except in Brazil, Japan, and Mexico). The agreement cancels all remaining patent litigation, including Mylan’s Inter Partes Review, which sought to invalidate 2 key patents on trastuzumab. It is assumed that Genentech and Hoffman-LaRoche will obtain royalty payments as part of the settlement, but terms of the deal were not released.

Filed in November, the current deadline for FDA action on Mylan’s 351(k) application is September 3, 2017. Theirs is the first (and only) trastuzumab biosimilar application filed in the US. In a press release, Mylan CEO Heather Bresch stated, “There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the US and around the world.”

Mylan and Biocon’s partnership breaks out commercial control as follows: Mylan will sell the product in North America, Australia and New Zealand, and in Europe; Biocon will hold rights to sell the product elsewhere.

Assuming the FDA approves the agent according to schedule, this would represent the first biosimilar agent to be marketed in the US for the direct treatment of cancer. However, Europe may see their first oncological biosimilar earlier: Mylan submitted its application for licensing with the European Medicines Agency (EMA) in November 2016, Celltrion’s CT-P6 was also submitted that month in Europe, but Samsung Bioepis applied for approval in August 2016 and may be the first reviewed by EMA.